Glycine, N-methyl-, N-coco acyl derivs., sodium salts

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT assessment of the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistency

Based on the available data, Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) is considered to be readily biodegradable. Thus, the substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) has a log D (used for ionisable substances instead of log Kow) of 0.61 - 2.40 at pH 7, and -0.30 - 1.53 at pH 9 ( SPARC v4.6), measured for representative components, indicating low lipophilicity at the environmentally relevant pH of 7 and 9. Thus, according to “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017)” the substance show values below the screening criteria for aquatic organism (log Kow > 4.5). In addition, it is expected that the screening criterion for air-breathing organisms will not be met (log Kow > 2) as the log D is missing the trigger value for only one representative constituent (Sodium palmitoyl sarcosinate CAS 4028-10-8: log D = 2.40). This constituent of the UVCB Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) in only present in the UVCB at a low amount (5-15%). Thus, it is not expected that the influence of this constituent on bioaccumulation in air breathing organisms is very high. Furthermore, Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) is not classified for toxic for reproduction and repeated exposure according to Regulation (EC) No 1272/2008. Therefore, the substance is expected to have a low potential for bioaccumulation at the environmentally relevant pH of 7 and 9.

In addition, toxicokinetic considerations with regard to absorption, distribution, metabolisation and excretion of the substance provide further evidence for a low potential for bioaccumulation. Furthermore, the estimated BCF values also indicate that the potential for bioaccumulation is low. The estimated BCF values are 3.16 L/kg wet-wt (BCFBAF model v3.01 regression-based), 0.89 L/kg wet-wt (BCFBAF model v3.01 Arnot-Gobas, including biotransformation upper trophic) and 3.0 – 74.0 L/kg wet-wt (VEGA v1.2.3, CAESAR, Meylan and KNN models) and are thus well below the threshold value of 2000 L/kg for bioaccumulative substances, as laid down by the REACH regulation (EC) No 1907/2006, section 1 of Annex XIII.

In conclusion, the potential for bioaccumulation is expected to be low for Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1). Thus, the substance does not meet the screening criterion for bioaccumulation and it is not considered to be B or vB.

 

Toxicity

For the substance Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) the available acute effect concentrations are ≥ 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (algae) is ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is readily biodegradable. Therefore, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.

 

In conclusion, the substance is not PBT/vPvB.